OMEGA - Dietary Intervention - COPD Trial

Not Applicable

Recruiting

• Conditions: COPD, Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Home delivery Omega-3 rich Food; Behavioral: Home delivery Food; Behavioral: Dietary Motivational Coaching

• Registration Number: NCT05297279
• Lead Sponsor: Johns Hopkins University

Brief Summary

A randomized controlled trial of a food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve Chronic Obstructive Pulmonary Disease (COPD) outcomes and attenuate the adverse effects of particulate matter on respiratory health.

Investigators believe that study results will comprehensively address the impact of an evidence-based nutrition intervention on COPD health and provide a framework for dietary intervention within other chronic diseases disproportionately impacting susceptible, low-income populations.

Detailed Description

COPD is a leading cause of death in the US with low-income individuals experiencing increased prevalence and morbidity. Poor dietary intake is also prevalent in low-income communities and has been associated with adverse outcomes in populations with respiratory disease. Data generated from the investigators Johns Hopkins NIH/EPA funded Environmental Health Disparities Center was instrumental in showing that poor dietary patterns, and in particular low omega-3 polyunsaturated fatty acid intake, are prevalent in a low income population with COPD. Low omega-3 intake was associated with poor respiratory outcomes and exacerbated the adverse effects of indoor air pollution exposure on respiratory symptoms. Accordingly, diet likely represents an important modifiable risk factor in low income individuals with COPD.

Investigators proposed a 12-week (3 months) randomized controlled intervention trial of a home food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve COPD outcomes and attenuate the adverse effects of particulate matter (PM) on respiratory health. Willing participants with low omega-3 intake assessed during the screening visit will have 1:1 randomization to one of the treatment arms. Outcomes will be assessed monthly and dietary intake will be assessed at 3 months. After the 12-week (3 months) intervention, participants will be followed for an additional 3 months to assess sustainability of the intervention. Participants will be part of this study for 6 months.

The proposed research represents new lines of investigation to test a dietary intervention aimed at: (1) improving respiratory health, and (2) protecting against adverse effects of environmental exposures in low-income adults with COPD.

Investigators will also explore barriers and facilitators of the intervention in order to optimize the sustainability of future implementation strategies.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-03-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥ 40 years,
• Physician diagnosis of COPD,
• Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume in the First Second (FEV1)/ Forced Vital Capacity (FVC) <70% and FEV1 (% predicted) <80%. IF FEV1/FVC <70% and FEV1 (% predicted) ≥ 80%, additional requirement will be asked: CAT score ≥ 10. Also, IF available for screening purposes: participant can provide a previous pulmonary function testing (PFT) report within the last 6 months.
• Tobacco exposure ≥ 10 pack-years,
• Poverty criteria as determined by residing in a neighborhood with ≥10% of residents living in poverty, consistent with the definition of poverty area OR not access to private health insurance, OR only completed high school education or less.
• Low omega-3 intake (reported daily intake of EPA+DHA intake <500 mg via diet and/or supplement) at the screening visit, and
• Willing to comply with dietary recommendations

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Exclusion Criteria

• Participant planning to change residence during study period,
• Other chronic lung disease, except those with history of asthma if it felt by the investigator not to be a primary diagnosis.
• Pregnancy or breastfeeding and
• Reported unwillingness to eat seafood.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active/Intervention Treatment Arm	Home delivery Omega-3 rich Food	Participants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period.
Active/Intervention Treatment Arm	Dietary Motivational Coaching	Participants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period.
Control Treatment Arm	Home delivery Food	Participants will receive a voucher of weekly food voucher (with a specified amount) for home delivery. Participants in the control arm will also receive a single one-on-one session by a trained research staff member at the beginning of the study, which will be followed by weekly 30-minute calls with the participant during the 12-week intervention study period. The trained research staff member will assist with the online ordering of foods and will provide calls centered on general publicly available, guideline-based dietary recommendations without tailoring or personalization (no dietary coaching). This group will not receive guidance specifically about omega-3 fatty acids.

Primary Outcome Measures

Name	Time	Method
Change in COPD health status as assessed by the COPD assessment test	Baseline, months 1 and 2 follow up calls, 3 months and 6 months	COPD health status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire	Baseline, months 1 and 2 follow up calls, 3 months and 6 months	The Clinical COPD Questionnaire (CCQ) health-related quality of life questionnaire (HRQoL) with good psychometric properties. The CCQ consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). High scores indicate worse quality of life.

Secondary Outcome Measures

Name	Time	Method
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)	Baseline, 3 months and 6 months	Pulmonary function testing will be assessed as FEV1, that is FEV1 (adjusted for age, height, race and sex) according to the American Thoracic Society (ATS) guidelines.
Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire	Baseline, 3 months and 6 months	St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations.
Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations	Baseline, months 1 and 2 follow up calls, 3 months and 6 months	Investigators will collect participant's self-report number of exacerbation episodes due to moderate and/or severe COPD-related exacerbation including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization.
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted	Baseline, 3 months and 6 months	Pulmonary function testing will be assessed as FEV1% predicted.
Change in exercise capacity as assessed by the Six-Minute Walk Distance	Baseline, 3 months and 6 months	The Six-Minute Walk Distance (6MWD) is a test used as a measure of exercise capacity and functional status of participants.

Trial Locations

Locations (1)

Johns Hopkins Bayview Campus; 🇺🇸 Baltimore, Maryland, United States